Hydroxyprogesterone Caproate Solution for injection

What is this medicine?

HYDROXYPROGESTERONE (hye drox ee proe JES ter one) is a female hormone. This medicine is used in women who are pregnant and who have delivered a baby too early (preterm) in the past. It helps lower the risk of having a preterm baby again.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• blood clotting disorders

• breast, cervical, uterine, or vaginal cancer

• depression

• diabetes or prediabetes

• heart disease

• high blood pressure

• kidney disease

• liver disease

• lung or breathing disease, like asthma

• migraine headaches

• seizures

• vaginal bleeding

• an unusual or allergic reaction to hydroxyprogesterone, other hormones, medicines, foods, dyes, castor oil, benzyl alcohol, or other preservatives

• breast-feeding

How should I use this medicine?

This medicine is for injection into a muscle. It is given by a health care professional in a hospital or clinic setting. You are likely to get an injection once a week to prevent preterm delivery.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

• acetaminophen

• bupropion

• clozapine

• efavirenz

• halothane

• methadone

• nicotine

• theophylline, aminophylline

• tizanidine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Your condition will be monitored carefully while you are receiving this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• breast tissue changes or discharge

• changes in vision

• confusion, trouble speaking or understanding

• depressed mood

• increased hunger or thirst

• increased urination

• pain, redness, or irritation at site where injected

• pain, swelling, warmth in the leg

• shortness of breath, chest pain, swelling in a leg

• sudden numbness or weakness of the face, arm or leg

• sudden severe headaches

• trouble walking, dizziness, loss of balance or coordination

• unusually weak or tired

• vaginal bleeding

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• changes in emotions or moods

• diarrhea

• fluid retention and swelling

• nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.